The present invention relates generally to a system and method used in conjunction with an implantable medical device. More specifically, the present invention relates to a system and method of providing programming information relating to an implantable medical device based upon an abductive diagnostic reasoning strategy.
Cardiac disease affects millions of people throughout the world. Cardiac disease may cause the excitatory and conductive system of the heart to fail, resulting in an abnormal cardiac rhythm, usually referred to as arrhythmia. Some arrhythmias are very dangerous, and may lead to death of the patient. Other arrhythmias may be the origin of less threatening conditions, but for which medical treatment is nevertheless required. One of the possible treatments for patients is assistance by an implantable medical device (IMD).
Modern IMDs, such as pacemakers or defibrillators, are complicated electronic devices, capable of providing assistance on demand, i.e., when the excitatory and conductive system of the heart fails to operate normally. In order to accommodate specific patient needs, an IMD may be programmed by setting particular parameters such that the resulting therapy is optimal for the patient.
Overall IMD systems known in the art comprise several components, including an IMD, pacing and/or sensing leads, and a programmer. The leads connect the IMD to the heart of a patient. The IMD stores a variety of different types of diagnostic data which assist a clinician in evaluating both the operation of the heart of the patient and the operation of the IMD. The specific diagnostic data stored by the IMD includes a variety of information, including a real-time event recording of pacing events.
The programmer of the overall IMD system is a microprocessor-based device, which is a stand-alone unit commonly located at a hospital or within a clinician""s office. To utilize the programmer, it is positioned in proximity to the IMD. The programmer is capable of communicating with the IMD and displaying information on a display screen. Depending upon the specific programmer, the programmer may be capable of reading information from and transmitting information to the IMD. Other programmers are only capable of monitoring or receiving information from the IMD, without the capability of transmitting information to the IMD. The programmer of the overall IMD system provides multiple functions, including assessing lead performance during a pacemaker or a defibrillator implantation, receiving feedback information from the IMD for use by the clinician, and, depending upon the specific programmer, programming the IMD.
An analyzer, which is sometimes a sub-component of the programmer and sometimes an individual component, is also a microprocessor-based device. The analyzer assists the clinician in assessing the electrical performance of a pacing lead system used in conjunction with an IMD system. The analyzer utilizes the programmer as a control and display platform.
There are numerous instances in which diagnostic data must be monitored during an adjustment procedure or must be retrieved from the IMD and displayed on the display screen of the programmer. For example, during a routine visit of the patient to a clinic, it is often necessary to retrieve information related to the IMD or the patient. Second, during a visit to a clinic, a clinician may want to perform a series of tests on the patient and view a variety of information related to the IMD and the patient. Third, during a medical procedure on the patient unrelated to the IMD, it may be necessary to monitor and/or adjust various parameters of the IMD prior to the medical procedure to ensure adequate performance of the IMD during the unrelated medical procedure.
An IMD and a programmer communicate with each other by means of an inductive transreceiver coil located within the programmer and an inductive transreceiver coil located within the IMD. In addition, the IMD includes a programmer detection system which detects the presence of a programmer in proximity to the IMD. For example, the programmer detection system is in a first state when a programmer is not proximal to the IMD. However, when a programmer is proximal to the IMD, the programmer detection system changes from the first state to a second state. With the programmer detection system in the second state, indicating the presence of a programmer proximal to the IMD, a communication system within the IMD is permitted to communicate with the programmer via the inductive transreceiver coils.
Unfortunately, reprogramming an IMD is not an easy task. Both sufficient time and knowledge of various IMD therapies must be available. In many patients, specific IMD therapy is sub-optimal due to a lack of one or both of these factors. In many situations, the original factory settings for an IMD are kept unchanged. On the one hand, technology relating to IMDs is moving fast, and the role of software programming is increasing, yielding IMDs that are constantly enhanced in their capabilities. On the other hand, there are limitations of what clinicians can and are willing to do with respect to customizing settings of an IMD for a particular patient. They are beginning to realize that some form of intelligent decision support is needed in order to permit patients to benefit from further advances in IMD technology.
The patents listed in Table 1 are examples of different systems and methods, which attempt to aid a clinician in accessing the efficiency of an IMD with respect to a specific patient.
All patents listed in Table 1 above are hereby incorporated by reference herein in their respective entireties. As those or ordinary skill in the art will appreciate readily upon reading the Summary of the Invention, Detailed Description of the Preferred Embodiments, and claims set forth below, many of the devices and methods disclosed in the patents of Table 1 may be modified advantageously by using the teachings of the present invention.
One disadvantage of prior art systems, including those listed in Table 1, relates to the inefficiency of the systems to properly provide programming/reprogramming information relating to relevant tests to be performed for further evaluation of an IMD or relating to optimal settings for a specific IMD implanted in a specific patient. Another disadvantage of prior art systems is the inability to provide a structured, systematic approach to identifying proper IMD setting and the inability to prompt a clinician to perform addition test or analysis.
Therefore, there is a continuing need for a system and method which provides a clinician with information relating to an IMD and a patient such that the clinician can quickly and easily identify additional relevant tests or provide the optimal setting for IMD therapy.
The present invention overcomes the disadvantages of the prior art by providing a method of and a system for providing programming information relating to an implantable medical device based upon an abductive diagnostic reasoning strategy.
The present invention has certain objects. That is, the present invention provides solutions to certain problems existing in the prior art such as: (a) an inability to identify at least one cause of an abnormal condition relating to an implantable medical device; (b) an inability to provide optimal programming information relating to an implantable medical device; (c) an inability to utilize an abductive diagnostic reasoning strategy to provide optimal programming information for an implantable medical device; (d) an inability to provide a systematic method capable of evolving based upon previous determined information, resulting in the determination of optimal programming information relating to an implantable medical device;(e) an inability to categorize information relating to an abnormal condition associated with the implantable medical device or a patient into one of three solution categories: rejected solutions, suspected solutions, or confirmed solutions; (f) an inability to compare observed findings relating to an abnormal condition to predicted findings based upon a model of abnormal behavior; and (g) an inability to display abnormal conditions associated with an implantable medical device and display suggested updated settings for the implantable medical device.
The system and method of the present invention provides certain advantages, including: (a) the ability to identify at least one cause of an abnormal condition relating to an implantable medical device; (b) the ability to provide optimal programming information relating to an implantable medical device; (c) the ability to utilize an abductive diagnostic reasoning strategy to provide optimal programming information for an implantable medical device; (d) the ability to provide a systematic method capable of evolving based upon previous determined information, resulting in the determination of optimal programming information relating to an implantable medical device;(e) the ability to categorize information relating to an abnormal condition associated with the implantable medical device or a patient into one of three solution categories: rejected solutions, suspected solutions, or confirmed solutions; (f) the ability to compare observed findings relating to an abnormal condition to predicted findings based upon a model of abnormal behavior; and (g) the ability to display abnormal conditions associated with an implantable medical device and display suggested updated settings for the implantable medical device.
The system and method of the present invention has certain features, including a model of abnormal conditions used as a basis for determining optimal settings for a particular implantable medical device in conjunction with a specific patient. The model of abnormal conditions provides that predicted abnormal findings with may be compared to actual observed findings associated with an implantable medical device. A causal model is capable of identifying at least one cause of an abnormal condition, while an abductive inference engine is capable of identifying suggested updated settings for the implantable medical device in response to the abnormal conditions.